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Twice-Weekly Etanercept Highly Effective Against Chronic Plaque Psoriasis: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 10, 2004 -- Etanercept (EnbrelŪ) achieves significant and consistent efficacy for chronic plaque psoriasis, according to pooled clinical-study data presented yesterday at the American Academy of Dermatology (AAD) 62^nd Annual meeting.

"We saw a very high rate of clearing at Week 12 for the highest dosing group, with robust numbers for all active treatment groups," said lead investigator Kenneth Gordon, MD, clinical dermatologist and associate professor, Loyola University Medical Center, Maywood, Illinois, United States.

Investigators analysed data on 1187 subjects, in this retrospective analysis of 3 phase II and III studies of etanercept for chronic plaque psoriasis. The researchers compared efficacy and safety for different dosing groups: 25 mg twice weekly (n = 415); 50 mg twice weekly (n = 358); and placebo (n = 773).

The primary endpoint of the analysis was PASI 75 at 12 weeks of treatment: an improvement of symptoms greater than or equal to 75%. The researchers reported that 3% of placebo subjects and 33% of those in the 25 mg twice weekly etanercept group achieved a Psoriasis Area and Severity Index (PASI) score of 75 (P < .0001). "In the 2 studies that included the highest dosage, 3% of patients receiving placebo and 49% of those receiving 50 mg twice weekly achieved a PASI 75 (P < .0001)," the researchers wrote.

In both etanercept dosing groups, significant efficacy was achieved for all secondary end points at Week 12, including: physician-/dermatologist-reported end points of PASI 50 and 90 responses; percent improvement from baseline in PASI score; dermatologist's static global assessment of clear or almost-clear psoriasis; Dermatology Life Quality Index (DLQI) and all DLQI subscales; and the patient's global assessment.

"Patients showed a high degree of psoriasis clearing, [and there was] improvement in both physician- and patient-reported outcomes, and significant impact on quality of life," the authors reported.

Etanercept is an injectable anti-TNF drug that is approved in the United States to treat the symptoms of moderate to severe rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, and alkylosing spondylitis.

The study was supported by Immunex Corporation, a wholly owned subsidiary of Amgen, Inc. and Wyeth.


[Study title: Efficacy of Etanercept in an Integrated Multi-Study Database of Patients With Psoriasis. Abstract 8]

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